Resorbable, macro-porous, non-collapsing and flexible membrane barrier for skeletal repair and regeneration

A method of facilitating protected bone regeneration, comprising the following steps:

• providing a substantially planar sheet of resorbable polymer base material excluding paper, the substantially planar sheet of resorbable polymer base material having a first side and a second side and comprising a single layer of resorbable polymer base material between the first side and the second side, the single layer of resorbable polymer base material having a substantially uniform composition, the substantially planar sheet of resorbable polymer base material further having a thickness and a plurality of non-intersecting apertures penetrating completely through the thickness of the substantially planar sheet of resorbable polymer base material from the first side to the second side, the plurality of non-intersecting apertures being substantially uniformly distributed over the substantially planar sheet of resorbable polymer base material, each of the non-intersecting apertures defining an isolated fluid-flow path extending through the thickness of the substantially planar sheet of resorbable polymer base material and having a diameter from about 500 microns to about 3000 microns in a pre-implant configuration of the substantially planar sheet of resorbable polymer base material, the pre-implant configuration being defined as a configuration of the substantially planar sheet of resorbable polymer base material immediately before the substantially planar sheet of resorbable polymer base material is formed around and implanted over a biological tissue defect and placed into contact with any adjacent soft tissue;
• and
• securing the substantially planar sheet of resorbable polymer base material over and around a bone defect area, to thereby cover and protect the entire bone defect area and to overlap adjacent areas of bone near the bone defect area, the substantially planar sheet of resorbable polymer base material having a configuration and strength sufficient to prevent prolapse of adjacent soft tissues into the bone defect area and to facilitate protected bone regeneration independently, without any aid from a fixation device, when the substantially planar sheet of resorbable polymer base material is secured over the bone defect area and secured to the adjacent areas of bone near the bone defect area, wherein each of the non-intersecting apertures of the secured substantially planar sheet of resorbable polymer base material has a diameter sufficient in size to allow a proliferation of vasculature and connective tissue cells, derived from adjacent soft tissues, to permeate through the plurality of non-intersecting apertures and into the biological tissue defect.

An implant for protecting a biological tissue defect from a prolapse of adjacent soft tissues during in vivo repair of the biological tissue defect, the implant having a pre-implant configuration, which is defined as a configuration of the implant immediately before the implant is implanted over the biological tissue defect and placed into contact with any adjacent soft tissue, the implant comprising;

• a substantially planar sheet of resorbable polymer base material excluding paper and having a first side and a second side, the substantially planar sheet of resorbable polymer base material comprising a single layer of resorbable polymer base material between the first side and the second side, the single layer of resorbable polymer base material further having a substantially uniform composition;
• and
• a plurality of apertures disposed in the substantially planar sheet of resorbable base material, each of the plurality of apertures of the implant when the implant is in the pre-implant configuration having a diameter from about 500 microns to about 3000 microns and defining an isolated fluid-flow path which extends from the first side to the second side, each isolated fluid-flow path being defined along an individual path axis, which comprises a substantially straight line, and having a substantially constant cross-sectional area at every point along a length of the path axis between the first side and the second side;
• wherein the implant comprises a configuration and strength sufficient to prevent gross prolapse of adjacent soft tissue into the biological tissue defect;
• and
• wherein each of the plurality of apertures of the implant, immediately after the implant is implanted over the biological tissue defect and placed into contact with any adjacent soft tissue, has a diameter sufficient in size to allow a proliferation of vasculature and connective tissue cells, derived from the adjacent soft tissues, to permeate through the aperture and substantially into the biological tissue defect.

An implant for protecting a biological tissue defect from a prolapse of adjacent soft tissues during in vivo repair of the biological tissue defect, the implant having a pre-implant configuration, which is defined as a configuration of the implant immediately before the implant is implanted over the biological tissue defect and placed into contact with any adjacent soft tissue, the implant comprising:

• a substantially planar sheet of resorbable polymer base material excluding paper and having a first side and a second side, the substantially planar sheet of resorbable polymer base material comprising a single layer of resorbable polymer base material between the first side and the second side, the single layer of resorbable polymer base material having a substantially uniform composition;
• and
• a plurality of tunnels disposed in the substantially planar sheet of resorbable base material, each of the plurality of tunnels of the implant when the implant is in the pre-implant configuration having a diameter from about 500 microns to about 3000 microns and defining an isolated fluid-flow path which extends from the first side to the second side, each of the plurality of tunnels of the implant, immediately after the implant is implanted over the biological tissue defect and placed into contact with any adjacent soft tissue, having a diameter sufficient in size to allow a proliferation of vasculature and connective tissue cells, derived from the adjacent soft tissues, to permeate through the tunnel and into the biological tissue defect, the implant comprising a configuration and strength sufficient to prevent gross prolapse of adjacent soft tissue into the biological tissue defect;
• wherein none of the fluid-flow paths intersect;
• and
• wherein none of the fluid-flow paths share any common volume.

An implant for protecting a biological tissue defect from a prolapse of adjacent soft tissues during in vivo repair of the biological tissue defect, the implant having a pre-implant configuration, which is defined as a configuration of the implant immediately before the implant is implanted over the biological tissue defect and placed into contact with any adjacent soft tissue, the implant comprising:

• a substantially planar sheet of resorbable polymer base material excluding paper and having a first side and a second side, the substantially planar sheet of resorbable polymer base material comprising a single layer of resorbable polymer base material between the first side and the second side, the single layer of resorbable polymer base material having a substantially uniform composition;
• and
• a plurality of apertures disposed in the substantially planar sheet of resorbable polymer base material, each of the plurality of apertures of the implant when the implant is in the pre-implant configuration being surrounded by and defined by an aperture wall within the substantially planar sheet of resorbable polymer base material, each of the plurality of apertures defining a fluid flow path from the first side to the second side;
• wherein each aperture wall of the implant when the implant is in the pre-implant configuration extends substantially and continuously from the first side to the second side, to thereby define a corresponding aperture which extends substantially and continuously from the first side to the second side;
• wherein each of the plurality of apertures of the implant when the implant is in the pre-implant configuration has a diameter within a range from approximately 500 microns to approximately 3000 microns, the diameter of each of the plurality of apertures of the implant, immediately after the implant is implanted over the biological tissue defect and placed into contact with any adjacent soft tissue, having a diameter sufficient in size to allow a proliferation of vasculature and connective tissue cells, derived from the adjacent soft tissues, to permeate through the aperture and into the biological tissue defect;
• and
• wherein the implant comprises a configuration and strength sufficient to prevent gross prolapse of the adjacent soft tissue into the biological tissue defect.